DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Claims 1-20 are pending. Claims 14-20 are withdrawn as directed to a non-elected invention. Claims 7, 9-11, and 13 are withdrawn as directed to a non-elected species. Claims 1-6, 8, and 12 are presently considered.
Election/Restrictions
Applicant’s election without traverse of Group I (products, original claims 1-13) and the species of SEQ ID NO: 29 in the reply filed on 8/24/2026 is acknowledged.
The originally elected species is understood to be the species of SEQ ID NO: 29 at Table 3 and Example 2 of the specification. SEQ ID NO: 29 is understood to have the following sequence:
rRrXrRrXrRrRXrRrR-NH2
Wherein “r” is D-arginine, and X is 8-aminooctanoid acid. SEQ ID NO: 29 may also be written as
rRr-(Aoa)-rRr-(Aoa)-rRrR-(Aoa)-rRrR-NH2
(see, e.g., Table 1 on page 4 of the Spec. filed 2/28/2024). This species is understood to correspond to the CAS Reg Number 2917695-82-8. Applicant alleges that the originally elected species reads upon instant claims 1-8, 11, and 13 (see, e.g., Reply filed 8/24/2026 at 1-2 at bridging ¶). This appears to be incorrect because claims 11 and 13 are directed to peptide-conjugates, and SEQ ID NO: 29 is a peptide satisfying the limitations of instant claim 1 (i.e., no additional “conjugate” is present), wherein no conjugate portion is identified, and wherein the C-terminus of SEQ ID NO: 29 is -NH2, which does not unambiguously fall within the enumerated categories of claims 11 and 13. However, the elected species reasonably reads upon claim 12. Accordingly, the originally elected species is understood to read upon instant claims 1-8 and 12, but not upon claims 9-11 or 13.
Following extensive search and examination, the originally elected species has been deemed free of the prior art. Per MPEP § 803.02(III)
If the examiner determines that the elected species is allowable over the prior art, the examination of the Markush claim will be extended. If prior art is then found that anticipates or renders obvious the Markush claim with respect to a nonelected species, the Markush claim shall be rejected; claims to the nonelected species would still be held withdrawn from further consideration. The prior art search will not be extended unnecessarily to cover all nonelected species.
Accordingly, Examination was extended to a non-elected species of instant SEQ ID NOs: 4-52, 55-59, and 74-98, wherein SEQ ID NO: 4, which is CAS NO. 2917695-57-7; SEQ ID NO: 5, which is CAS NO. 2917695-58-8; SEQ ID NO: 6, which is CAS NO. 2917695-59-9; SEQ ID NO: 7, which is CAS NO. 2917695-60-2; SEQ ID NO: 8, which is CAS NO. 2917695-61-3; SEQ ID NO: 9, which is CAS NO. 2917695-62-4; SEQ ID NO: 10, which is CAS NO. 2917695-63-5; SEQ ID NO: 11, which is CAS NO. 2917695-64-6; SEQ ID NO: 12, which is CAS NO. 2917695-65-7; SEQ ID NO: 13, which is CAS NO. 2917695-66-8; SEQ ID NO: 14, which is CAS NO. 2917695-67-9; SEQ ID NO: 15, which is CAS NO. 2917695-68-0; SEQ ID NO: 16, which is CAS NO. 2917695-69-1; SEQ ID NO: 17, which is CAS NO. 2917695-70-4 ; SEQ ID NO: 18, which is CAS NO. 2917695-71-5; SEQ ID NO: 19, which is CAS NO. 2917695-72-6; SEQ ID NO: 20, which is CAS NO. 2917695-73-7; SEQ ID NO: 21, which is CAS NO. 2917695-74-8; SEQ ID NO: 22, which is CAS NO. 2917695-75-9; SEQ ID NO: 23, which is CAS NO. 2917695-76-0; SEQ ID NO: 24, which is CAS NO. 2917695-77-1; SEQ ID NO: 25, which is CAS NO. 2917695-78-2; SEQ ID NO: 26, which is CAS NO. 2917695-79-3; SEQ ID NO: 27, which is CAS NO. 2917695-80-6; SEQ ID NO: 28, which is CAS NO. 2917695-81-7; SEQ ID NO: 29, which is CAS NO. 2917695-82-8; SEQ ID NO: 30, which is CAS NO. 2917695-83-9; SEQ ID NO: 31, which is CAS NO. 2917695-84-0; SEQ ID NO: 32, which is CAS NO. 2917695-85-1; SEQ ID NO: 33, which is CAS NO. 2917695-86-2; SEQ ID NO: 34, which is CAS NO. 2917695-87-3; SEQ ID NO: 35, which is CAS NO. 2917695-88-4; SEQ ID NO: 36, which is CAS NO. 2917695-89-5; SEQ ID NO: 37, which is CAS NO. 2917695-90-8; SEQ ID NO: 38, which is CAS NO. 2917695-91-9; SEQ ID NO: 39, which is CAS NO. 2917695-92-0; SEQ ID NO: 40, which is CAS NO. 2917695-93-1; SEQ ID NO: 41, which is CAS NO. 2917695-94-2; SEQ ID NO: 42, which is CAS NO. 2917695-95-3; SEQ ID NO: 43, which is CAS NO. 2917695-96-4; SEQ ID NO: 44, which is CAS NO. 2917695-97-5 ; SEQ ID NO: 45, which is CAS NO. 2917695-98-6; SEQ ID NO: 46, which is CAS NO. 2917695-99-7; SEQ ID NO: 47, which is CAS NO. 2917696-00-3; SEQ ID NO: 48, which is CAS NO. 2917696-01-4; SEQ ID NO: 49, which is CAS NO. 2917696-02-5; SEQ ID NO: 50, which is CAS NO. 2917696-03-6; SEQ ID NO: 51, which is CAS NO. 2917696-04-7; SEQ ID NO: 52, which is CAS NO. 2917696-05-8; SEQ ID NO: 55, which is CAS NO. 2917696-08-1; SEQ ID NO: 56, which is CAS NO. 2917696-09-2; SEQ ID NO: 57, which is CAS NO. 2917696-10-5; SEQ ID NO: 58, which is CAS NO. 2917696-11-6; SEQ ID NO: 59, which is CAS NO. 2917696-12-7; SEQ ID NO: 74, which is CAS NO. 2917696-27-4; SEQ ID NO: 75, which is CAS NO. 2917696-28-5; SEQ ID NO: 76, which is CAS NO. 2917696-29-6; SEQ ID NO: 77, which is CAS NO. 2917696-30-9; SEQ ID NO: 78, which is CAS NO. 2917696-31-0; SEQ ID NO: 79, which is CAS NO. 2917696-32-1; SEQ ID NO: 80, which is CAS NO. 2917696-33-2; SEQ ID NO: 81, which is CAS NO. 2917696-34-3; SEQ ID NO: 82, which is CAS NO. 2917696-35-4; SEQ ID NO: 83, which is CAS NO. 2917696-36-5; SEQ ID NO: 84, which is CAS NO. 2917696-37-6; SEQ ID NO: 85, which is CAS NO. 2917696-38-7; SEQ ID NO: 86, which is CAS NO. 2917696-39-8; SEQ ID NO: 87, which is CAS NO. 2917696-40-1; SEQ ID NO: 88, which is CAS NO. 2917696-41-2; SEQ ID NO: 89, which is CAS NO. 2917696-42-3; SEQ ID NO: 90, which is CAS NO. 2917696-43-4; SEQ ID NO: 91, which is CAS NO. 2917696-44-5; SEQ ID NO: 92, which is CAS NO. 2917696-45-6; SEQ ID NO: 93, which is CAS NO. 2917696-46-7; SEQ ID NO: 94, which is CAS NO. 2917696-47-8; SEQ ID NO: 95, which is CAS NO. 2917696-48-9; SEQ ID NO: 96, which is CAS NO. 2917696-49-0; SEQ ID NO: 97, which is CAS NO. 2917696-50-3; and SEQ ID NO: 98, which is CAS NO. 2917696-51-4, are all deemed free of the prior art.
Examination was then extended to the non-elected species of SEQ ID NO: 3 as well as the non-elected species of (Arg)8, reading upon the Markush claim (i.e., instant claim 1). Per MPEP § 803.02(III)(A),
Following election, the Markush claim will be examined fully with respect to the elected species and further to the extent necessary to determine patentability. Note that where a claim reads on multiple species, only one species needs to be taught or suggested by the prior art in order for the claim to be anticipated or rendered obvious...
If the Markush claim is not allowable, the provisional election will be given effect and examination will be limited to the Markush claim and claims to the elected species, with claims drawn to species patentably distinct from the elected species held withdrawn from further consideration.
The non-elected species is understood to read upon instant claims 1-6 and 12. Critically, claims 7, 9, 11, and 13 do not read upon the non-elected species and are directed to species that are patentably distinct from the originally elected species of SEQ ID NO: 291, and therefore these claims are withdrawn from further consideration at this time. Claim 8 is directed to the originally elected species, and has been fully examined and identified as directed to allowable subject matter, but claim 8 is objected to as explained below.
Claims 14-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/24/2026.
Claims 7, 9, 10-11, and 13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/24/2026.
Claims 1-6, 8, and 12 are presently considered.
Denial of Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, US Provisional 63260836 (filed 9/01/2021) and US Provisional 63268158 (filed 2/17/2022) each fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
The MPEP states that "[w]hile there is no in haec verba requirment, . . . . claim limitations must be supported in the specification through express, implicit, or inherent disclosure." See MPEP § 2163.
Lack of Express Support
Claim 1 is representative of the pending claim scope. Claim 1 does not literally appear in either Pro’836 or Pro’158, and therefore the claims lack literal support in these provisionals.
More specifically, the instant claims read upon formulas wherein block-1, block-2, block-3, and block-4 may comprise 2 to 7 amino acids independently selected from a group including homoarginine (Har), but the provisional applications do not literally teach, disclose, nor identify a genus including homoarginine (Har).
Accordingly, Pro’836 or Pro’158 each fail to provide literal support for the pending claim scope that is synonymous or equivalent in scope.
Lack of Implicit or Inherent Support
The MPEP states that "[w]hile there is no in haec verba requirment, . . . . claim limitations must be supported in the specification through express, implicit, or inherent disclosure." See MPEP § 2163. In the absence of express support, the relevant issue is whether or not the claimed invention is supported by Pro’231 through implicit or inherent disclosures.
Upon review, zero inherent or implicit support commensurate in scope with the metes and bounds of the instant claims is found in either Pro’836 or Pro’158, at least because homoarginine (Har) is not implicitly or inherently disclosed in any reduction to practice, Har is not identified as synonymous or equivalent in scope to L-arginine or D-arginine, and the provisionals are silent regarding the usage of Har in the recited genus. According, the claim language presently claimed is not supported by the provisional document by synonymous or equivalent language.
Accordingly, Pro’836 or Pro’158 fails to provide implicit or inherent support for the pending claim scope that synonymous or equivalent in scope, or otherwise commensurate in scope with the pending claims.
Conclusion
Accordingly, priority to US Provisional 63260836 (filed 9/01/2021) and US Provisional 63268158 (filed 2/17/2022) is denied for claim 1 and all of the dependents of claim 1; these claims have been accorded a priority date of 9/01/2022, which corresponds to the filing date of PCT/US2022/042312 (filed 9/01/2022).
Information Disclosure Statement
The IDS filed 6/28/2024 and 9/03/2025 are each acknowledged and presently considered.
Claim Interpretation
For purposes of examination, the claim scope has been interpreted as set forth below per the guidance set forth at MPEP § 2111. If Applicant disputes any interpretation, Applicant is invited to unambiguously identify any alleged misinterpretations or specialized definitions in the subsequent response to the instant action. Applicant is advised that a specialized definition should be properly supported and specifically identified (see, e.g., MPEP § 2111.01(IV), describing how Applicant may act as their own lexicographer).
Claim 1 is representative of the pending claim scope and presently recites a formula of
Sl-[block-l]m-x-[block-2]n-y-[block-3]o-z-[block-4]p-S2
It is noted that if S1 and S2 are optionally present, and if absent, the formula simplifies to
[block-l]m-x-[block-2]n-y-[block-3]o-z-[block-4]p
Examiner also notes that the linkers of x, y, and z may be “present or absent”. If absent, the formula simplifies to
[block-l]m-[block-2]n-[block-3]o-[block-4]p
The indices of m, n, o, and p are 0 or 1; subject to provisos, wherein at least two are “1”, and wherein:
when m is 1 and n is 0, x is absent;
when m is 0 and n is 1, x is absent;
when n is 1 and o is 0, y is absent;
when n is 0 and o is 1, y is absent;
when o is 1 and p is 0, z is absent; and
when o is 0 and p is 1, z is absent
Notably, when each of x, y, and z are absent these provisos are necessarily satisfied. A minimum structure may be identified by permitting any two of m, n, o, and p to be 1, while the others are zero, which yields a minimum structure of
[(X)2-7]-[(X)2-7]
Where “X” is independently L-Arg, D-Arg, or homoarginine (Har). Similarly, an additional minimized structure may be identified by permitting each of m, n, o, and p to be 1, which yields
[(X)2-7]-[(X)2-7]-[(X)2-7]-[(X)2-7]
Where “X” is independently L-Arg, D-Arg, or homoarginine (Har). Accordingly, claim 1 fully encompasses any peptide comprising (X)4-28, wherein “X” is independently L-Arg, D-Arg, or homoarginine (Har).
The transitional phrase of “having” is used at claim 1. Per MPEP § 2111.03(IV), transitional phrases other than those discussed at MPEP §§ 2111.03(I)-(III) “must be interpreted in light of the specification to determine whether open or claimed claim language is intended” (see, e.g., MPEP § 2111.03(IV)). In the absence of clear guidance to the contrary, the transition phrase “having” has been interpreted as equivalent to “comprising” and is open-ended (see, e.g., MPEP § 2111, noting that the broadest reasonable interpretation is given during prosecution). This interpretation is reasonable in view of dependent claims 11 and 13, which are drawn to peptide-conjugates comprising the peptide of claim 1. If Applicant disagrees, Applicant should identify if the transitional phrase is intended to be open-ended or closed and direct Examiner to disclosures in the originally filed disclosure that support the Applicant’s position. Alternatively, Examiner notes that the issue could be clarified by simply amending the claim to use common transitional phrases set forth at MPEP §§ 2111.03(I)-(III), such as “comprising” or “consisting of”.
Regarding “optionally” present components at claim 1, per MPEP § 2111.04(I), “[c]laim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure”. Accordingly, such recitations are not limiting.
Additional claim interpretations are set forth below.
Claim Rejections
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 5-6, and 12 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being clearly anticipated by US 8088888 (O’Neil; Jan. 3, 2012).
Claim interpretation: The applicable claim interpretation has been set forth in a preceding section above, and those interpretations are incorporated into the instant rejection. Additional claim interpretations are set forth below.
Regarding instant claims 1-3, 5-6, 12, and peptides of form (Arg)4-28, US’888 discloses SEQ ID NO: 6 (RRRRRRR), and recites and claims methods utilizing peptides consisting of “3 to 50 contiguous arginine residues”, and peptides consisting of “3 to 15 or 3 to 7 contiguous arginine residues” (see, e.g., US’888 at col 5 at lines 5-10, SEQ ID NO: 6, claims 1 and 3). Accordingly, in view of US’888, an artisan would at once envisage polypeptides consisting of 4 to 28 contiguous arginine residues (i.e., the 24 members of the genus (Arg)4-28 are anticipated by the prior art). Regarding instant claims 1-3, 5-6, and limitations pertaining to Formula I, the prior art polypeptides of (Arg)4-28 satisfy the requirements of Formula I and dependent claims 1-3 and 5-6, wherein, in Formula I
Sl-[block-l]m-x-[block-2]n-y-[block-3]o-z-[block-4]p-S2
S1 and S2 are absent; and x, y, z are also absent, which yields
[block-l]m-[block-2]n-[block-3]o-[block-4]p
Critically, wherein any two of m, n, o, and p is 1, while the others are zero, this yields a minimum structure of
[(X)2-7]-[(X)2-7]
Where “X” is independently L-Arg, D-Arg, or homoarginine (Har). Specifically, this minimal structure reads upon (Arg)4-14. Alternatively, when each of m, n, o, and p are all 1, the simplified formula becomes
[(X)2-7]-[(X)2-7]-[(X)2-7]-[(X)2-7]
Where “X” is independently L-Arg, D-Arg, or homoarginine (Har). This reads upon polyarginine structures of lengths 8-28, or (Arg)8-28. Accordingly, the prior art disclosure of US’888, which anticipates all members of the genus (Arg)4-28, satisfies all structural limitations recited at instant claims 1-3 and 5-6, and these peptides would be at once envisaged in view of US’888. Regarding instant claim 12 and pharmaceutical formulations comprising a polypeptide of form (Arg)4-28, US’888 expressly claims and directs artisans to methods requiring the existence of pharmaceutical compositions suitable “for the treatment of an infection caused by a fungal pathogen in a subject”, wherein such pharmaceutical compositions would necessarily comprise one or more polypeptides of the genus (Arg)4-28 and a pharmaceutically acceptable carrier suitable for oral, parenteral, rectal, dermal, transdermal or other routes (see, e.g., US’888 at claims 1 and 3-6).
Accordingly, claims 1-3, 5-6, and 12 are rejected.
Claims 1-3 and 5-6 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being clearly anticipated by US 7125839 (Oct. 24, 2006).
Claim interpretation: The applicable claim interpretation has been set forth in a preceding section above, and those interpretations are incorporated into the instant rejection. Additional claim interpretations are set forth below.
Regarding instant claims 1-3 and 5-6, US’839 teaches and discloses SEQ ID NO: 213, which is Arg-Arg-Gly-Arg-Arg-Gly-Arg-Arg-Gly-Arg-Arg, identified as an arginine protein transduction tag (see, e.g., US’839 at SEQ ID NO: 213, SEQ ID NO: 213 at <223>). This sequence satisfies the requirements of instant claims 1-3 and 5-6 where in Formula I of instant claim 1
Sl-[block-l]m-x-[block-2]n-y-[block-3]o-z-[block-4]p-S2
S1 and S2 are absent; and x, y, z are each glycine, which yields
[block-l]1-Gly-[block-2]1-Gly-[block-3]1-Gly-[block-4]1
And further where block-1, block-2, block-3, and block-4 each comprise 2 amino acids, namely L-arginines:
[(Arg)2]1-Gly-[(Arg)2]1-Gly-[(Arg)2]1-Gly-[(Arg)2]1
(compare US’839 at SEQ ID NO: 213 with instant claims 1-3 and 5-6).
Accordingly, claims 1-3 and 5-6 are rejected.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-6 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over US2019/0144510A1 (Chih et al.; May 16. 2019).
Claim interpretation: The applicable claim interpretation has been set forth in a preceding section above, and those interpretations are incorporated into the instant rejection. Additional claim interpretations are set forth below.
Regarding instant claims 1-6 and 12, and antimicrobial peptides comprising arginine segments separated by linkers, US’510 discloses antimicrobial peptides (see, e.g., US’510 at title, abs, claims 1-8, ¶¶[0002]-[0003], [0029]-[0034], [0042]-[0047]). Regarding instant claim 12, US’510 expressly recites an overlapping claim scope of antimicrobial peptides, and explicitly claims may be combined with a pharmaceutically acceptable carrier to form a pharmaceutical composition for use in methods of treating microbial infections in subjects (see, e.g., US’510 at claims 1, 33-35).
US’510 differs from the instant claim scope as follows: US’510 does not explicitly teach or reduce to practice the specific structures of instant SEQ ID NOs: 2-3 or 542.
The pending claim scope, including instant SEQ ID NOs: 2-3 and 54 fall within the prior art genus of US’510: US’510 informs artisans of a genus of antimicrobial peptides having 100 or fewer amino acids, wherein the genus comprises peptides comprising 2-20 “variable domains” that may each consist of 2-20 “consecutive basic amino acids”, wherein the variable domains “are separated from each other by a variable linker”, wherein the “variable linker” can be 1-20 amino acids in length and comprise any amino acid (see, e.g., US’510 at claims 1-8, ¶¶[0002]-[0003], [0029]-[0034]), and wherein such structures could end with an optional C-terminal cysteine (see, e.g., US’510 at claims 3, ¶¶[0002], [0030]). This prior art genus may be written as:
[X2-20Y1-20]1-19-[X2-20]-[Cys]0-1
Where “X” is the variable domain, Y is the linker, and wherein the variable domain is repeated for a total of 2-20 times, separated by a variable linker. Critically, the prior art identifies that the “consecutive basic amino acid” (“X” above) may be L- or D-Arginine or “an analog thereof” (see, e.g., US’510 at claims 1-8, ¶¶[0030]-[0034]), and the linker is understood to read upon a single amino acid, such as glycine or proline (see, e.g., US’510 at ¶¶[0042]-[0047], SEQ ID NOs: 7-10, exemplifying linkers of glycine and proline). Accordingly, the prior art genus of US’510 fully encompasses and directs artisans to structures having the general form
[X2-7G]1-3-[X2-7]-[Cys]0-1
and
[X2-7P]1-3-[X2-7]-[Cys]0-1
Wherein “X” is L-arginine or D-arginine, and wherein the linker Y1 is glycine or proline. This prior art genus and subgenus substantially and materially overlaps in scope with the instant genus of Formula I
Sl-[block-l]m-x-[block-2]n-y-[block-3]o-z-[block-4]p-S2
Wherein S1 is absent, and S2 is either absent of cysteine; x, y, z may be present and would correspond to Y1 in each block, selected from glycine or proline, which yields
[block-l]m-x-[block-2]n-y-[block-3]o-z-[block-4]p-[Cys]0-1
Critically, wherein m, n, o, and p are each 1, this yields structures having the forms
[(X)2-7]-x-[(X)2-7]-y-[(X)2-7]-z-[(X)2-7]-[Cys]0-1;
Wherein x, y, and z may be simply written as “Y1”, which yields
[X2-7Y1]1-3-[X2-7]-[Cys]0-1
Furthermore, when Y1 is glycine or proline, this yields the prior art subgenus of
[X2-7G]1-3-[X2-7]-[Cys]0-1
and
[X2-7P]1-3-[X2-7]-[Cys]0-1
Wherein each “X” is independently L-Arg or D-Arg, and wherein each of x, y, and z are proline or glycine. This is identical to the subgenus of US’510, and illustrates that the instant claim scope substantially and materially overlaps in scope with the prior art.
Instant SEQ ID NOs: 2-3 and 54 appear to only perform the exact functions predicted and expected in view of the prior art: As shown above, the instant claim scope overlaps with the prior art, and therefore it is not surprising nor unexpected that compounds having the general form
[X2-7G]1-3-[X2-7]-[Cys]0-1
or
[X2-7P]1-3-[X2-7]-[Cys]0-1
(wherein “X” is L-arginine, D-arginine, or an analog or homolog thereof) act as antimicrobial peptides, because that is the expected and predicted result in view of the prior art disclosure, wherein such peptides are simply formed using known amino acids (L-Arg, D-Arg, Proline, Glycine, and Cys) in known arrangements, to obtain antimicrobial peptides having known and predicted applications, such as the treatment of antimicrobial infections, exactly as taught and suggested by the prior art (see, e.g., US’510 at claims 1, 33-35).
The mechanism of action for antimicrobial activity was disclosed by the prior art, and is understood to require “positive charge clusters”: Although the prior art, like the instant claims, provides a broad genus, the common structure responsible for antimicrobial activity identified by US’510 is understood to require about four, separated “positive charge clusters” or “four clustering arginine-rich domains” (see, e.g., US’510 at ¶¶[0020], [0061], claim 1). Accordingly, an artisan would readily appreciate that antimicrobial activity would be present in sequences having four, clustered “arginine-rich domains”. Accordingly, all members of the prior art genus share clusters of “arginine-rich domains”, which is understood to be responsible for observed and predicted antimicrobial activity (see, e.g., US’510 at ¶¶[0020], [0061], claims 1-8, 33-35). In view of US’510, all such structures within the claimed subgenus, would have already been predicted and expected to be antimicrobial peptides in view of US’510 (see, e.g., US’510 at claims 1-8, ¶¶[0002]-[0003], [0029]-[0034], [0042]-[0047]). Critically, each of instant SEQ ID NOs: 2-3, and 54 comprise four “arginine-rich domains”, separated by a linking residue, and therefore such sequences fall within the scope of the prior art genus, share the common structure required for activity as taught by the prior art (i.e., separated clusters of arginine residues), and appear to do nothing more than what was already taught and disclosed by the prior art.
Therefore, it would have been obvious to one of ordinary skill in the art, either before the effective filing date of the claimed invention (AIA ) or otherwise at the time the invention was made (pre-AIA ), to arrive at the instantly claimed invention in view of the prior art for at least the following reason(s): Per KSR, all that is needed to sustain a determination of obviousness is “A rationale to support a conclusion that a claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art” (see, e.g., KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 416, 82 USPQ2d 1385, 1395 (2007)); and "[W]hen a patent 'simply arranges old elements with each performing the same function it had been known to perform' and yields no more than one would expect from such an arrangement, the combination is obvious." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 , 417 , 127 S. Ct. 1727 , 167 L. Ed. 2d 705 (2007) (quoting Sakraida v. Ag Pro, Inc., 425 U.S. 273 , 282 , 96 S. Ct. 1532 , 47 L. Ed. 2d 784 (1976)). Here, all components were known in the prior art (e.g., L-Arginine, D-arginine, glycine or proline linkers), the function of each component was known in the prior art, and the known components were combined according to known methods of constructing antimicrobial peptides defined by shared, separated groups of clustered arginines as taught and disclosed by US’510, and the combination of such known components according to known methods would only yield predictable and expected results, namely antimicrobial peptides of form [X2-7G]1-3-[X2-7]-[Cys]0-1 or [X2-7P]1-3-[X2-7]-[Cys]0-1 (wherein “X” is L-arginine or D-arginine) usable in methods of treating microbial infections, exactly as taught, disclosed, and claimed by US’510 (see, e.g., MPEP §§ 2143(I)(A), 2144.08-2144.09)
No evidence of unexpected results commensurate in scope with the requirements of MPEP §§ 716, 716.01, and 716.02 have been placed on record to date.
Furthermore, there would be a reasonable expectation of success because the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)). Furthermore, it is well-within the ordinary skill in the art to combine and rearrange known components within a known pattern according to a known formula to obtain known and predicted results, exactly as taught and suggested by the prior art.
Accordingly, claims 1-6 and 12 are rejected.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US2010/0311821A1 (Geng; Dec. 9, 2010) pertains to compounds comprising one or more DNA binding peptides comprising R1-10P (see, e.g., US’821 at claims 1 and 9, ¶¶[0059]-[0063]).
Allowable Subject Matter
Claim 8 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RANDALL L BEANE whose telephone number is (571)270-3457. The examiner can normally be reached Mon.-Fri., 7 AM to 2 PM ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko G. Garyu can be reached at (571) 270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/RANDALL L BEANE/ Primary Examiner, Art Unit 1654
1 Although the claim may encompass the originally elected species, these claims also broadly recite numerous other species that are patentably distinct from the originally elected species. Accordingly, the claims have been examined to the extent they read upon the originally elected species, but are withdrawn as directed to unexamined, and patentably distinct species.
2Instant SEQ ID NO: 2 is rRr-G-rRr-G-rRrR-G-rRrR-Cys; instant SEQ ID NO: 3 is rRr-G-rRr-G-rRrR-G-rRrR-Cys; and instant SEQ ID NO: 54 is rRr-P-rRr-P-rRrR-P-rRrR
